Development and Preliminary Clinical Evaluation of a Novel Gelatin-Based Diclofenac Potassium-Medicated Lollipop for Post-adenotonsillectomy Pain Management in Children: A Prospective Pilot Study

Post-adenotonsillectomy pain is among the most clinically significant sources of postoperative morbidity in the paediatric population, and its management at home is frequently undermined by poor adherence to conventional oral analgesic formulations - a consequence of their bitter taste and the mechanical difficulty of swallowing during the acute postoperative period. This biphasic translational study describes the pharmaceutical development and preliminary clinical evaluation of a novel gelatin-carboxymethylcellulose hybrid diclofenac potassium-medicated lollipop, produced in three weight-adjusted paediatric dose strengths (15 mg, 20 mg, and 30 mg). Phase I encompassed iterative formulation optimisation, followed by full physicochemical characterisation - including pH, moisture content, viscosity, and drug content uniformity by high-performance liquid chromatography (HPLC) - and microbiological quality assessment, all conducted in accordance with United States Pharmacopoeia (USP 42) standards. The optimised formulation demonstrated a mean pH of 5.67 ± 0.20, uniform viscosity of 8.0 centipoise, HPLC-confirmed drug content of 100.7-102.9% of the labelled dose across all three strengths, and complete microbiological compliance. Phase II was a prospective clinical pilot study enrolling 50 children aged 4-12 years classified as American Society of Anesthesiologists (ASA) Physical Status I-II. ASA I indicates a healthy patient with no systemic disease, whereas ASA II refers to a patient with mild systemic disease without functional limitation. The lollipop was administered at eight-hour intervals for 24 hours postoperatively. Pain intensity was evaluated using the visual analogue scale (VAS) or Wong-Baker FACES Scale before and one hour after each dose. A consistent, progressive reduction in pain scores was observed across all three dose groups, with pain scores progressively decreasing across all dose groups, reaching minimal or absent pain by the third postoperative assessment. Overall taste and texture acceptability was rated positively by 83% of participants. No adverse events were recorded throughout the observation period. These findings establish the pharmaceutical viability and preliminary clinical promise of this formulation as a child-friendly analgesic vehicle and provide a compelling rationale for a powered randomised controlled trial with pharmacokinetic characterisation.